Assessment of a Composite Prognostic Score to Predict Severe Forms of Ischemic Colitis

Assessment of a Composite Prognostic Score to Predict Severe Forms of Ischemic Colitis of Montpellier

Our objective is to determine a prognostic score including CT, clinical and biological criteria predicting the serious (death / surgery) or non-serious (medical treatment) evolution of ischemic colitis and therefore possibly modify the therapeutic management (propose surgical treatment for a severe form based on prognostic score).

Study Overview

• Status: Completed
• Conditions: Ischemic Colitis

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Single-center retrospective cohort (center: CHU de Montpellier) of patients admitted between january 2014 and december 2019 at the CHU, over 18 years of age and having presented ischemic colitis during their stay, with completion of an injected abdomino-pelvic scanner within 6 hours of onset of symptoms, then proven by surgery or endoscopy

Description

Inclusion criteria:

• Age > or = at 18 years old;
• Performing an abdomino-pelvic scan injected within 6 hours of the onset of symptoms;
• Ischemic colitis proven by endoscopy or surgical data.

Exclusion criteria:

• CT scan performed without injection and / or after 6 hours following the onset of symptoms;
• Unproven ischemic colitis.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate of ischemic colitis	Severe (surgery and/or death) or non severe form of ischemic colitis (medical treatment) : analysis of radiological, biological and clinical data is performed at the time of acute episode of ischemic colitis when the patient is admitted to the hospital or during the stay of the patient previously present in the hospital for another condition	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Patrice TAOUREL, MD-PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: computed tomography; Ischemic colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Ischemia; Colitis; Colitis, Ischemic
• Other Study ID Numbers: RECHMPL20_0639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No